Diclokern Forte 23.2 mg/g gel

diclofenaco dietilamina

Read this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. Nevertheless, for the best results, it should be used properly.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, you should consult a doctor.
• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

6. Contents of the pack and additional information

The diclofenac diethylamine, active ingredient of this medication, belongs to the group of nonsteroidal anti-inflammatory drugs and acts topically as a local analgesic and anti-inflammatory.

Diclokern Forte is indicated in adults and adolescents over 14 years old for local relief of mild and occasional pain and inflammation caused by:

• small bruises, blows, strains
• stiff neck or other contractures
• occasional back pain (as a result of sports activities or during daily activities)
• mild sprains caused by a twist

Do not use Diclokern Forte:

• If you are allergic to diclofenac or any other nonsteroidal anti-inflammatory drug used to treat pain, fever, or inflammation, such as ibuprofen or acetylsalicylic acidor to any of the other components of this medication (see complete list in section 6).

The symptoms related to an allergic reaction to these medications may include: asthma, difficulty breathing, skin rash or itching, swelling in the face or tongue, and nasal discharge.

• If you are in the last 3 months of pregnancy.
• Do not apply on wounds, eczematous lesions, mucous membranes, or burns.
• If you are under 14 years old.

Be especially careful with Diclokern Forte:

• Do not apply on areas of the skin where there are open cuts or wounds, or on mucous membranes, or on eczema or areas of the skin where there is a skin rash. Stop using the medication if a skin rash occurs after application.
• Do not use on large areas. Use exclusively on the affected area.
• Avoid contact of Diclokern Forte with the eyes. If this occurs, rinse the eyes with clean water. Consult your doctor or pharmacist if you feel any discomfort afterwards.
• Do not use occlusive dressings (e.g., plastic dressings).
• Do not use more of the medication than indicated, or for a longer period than indicated, unless advised by your doctor.
• Do not apply Diclokern Forte simultaneously on the same area where other medications have been applied.
• Do not ingest this medication or use it in the mouth. Diclokern Forte is for external use only.Consult your doctor or pharmacist in case of accidental ingestion.
• The treated areas should not be exposed to the sun (even on cloudy days) or ultraviolet radiation lamps (UVA rays).
• Do not use during the first and second trimester of pregnancy, except on medical advice.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, especially analgesics, even those obtained without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use Diclokern Forte if you are in the last 3 months of pregnancy. Do not use Diclokern Forte during the first 6 months of pregnancy, unless strictly necessary and recommended by your doctor. If you need treatment during this period, you should take the minimum dose possible for the shortest time possible.

The oral formulations (e.g., tablets) of diclofenac may cause adverse reactions to the fetus. It is unknown if this same risk applies to Diclokern Forte when used on the skin.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use Diclokern Forte during breastfeeding, except as advised by your doctor.

Do not apply directly on the breast area.

Use in children

Do not use in children under 14 years old, as there is insufficient data available on efficacy and safety.

Driving and operating machinery

No effects on the ability to drive vehicles and operate machinery have been described when using Diclokern Forte externally on the skin.

Important information about some of the components of Diclokern Forte

This medication may cause skin irritation because it contains propylene glycol.

This medication may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes because it contains butylhydroxytoluene.

This medication may be slightly irritating to the skin, eyes, and mucous membranes because it contains hexyl benzoate.

Follow exactly the following administration instructions for Diclokern Forte, unless your doctor has told you otherwise. Consult your doctor or pharmacist if you have any doubts.

This medication is for use only on the skin (topical use).

The usual dose is:

Adults and adolescents over 14 years:Apply 2 times a day, every 12 hours, (preferably in the morning and at night) a small amount of gel to the affected or painful area.

The amount of gel will vary depending on the size of the affected area (usually, it will be enough to apply an amount similar to the size of a cherry or a walnut).

Method of use:

• To use the tube for the first time, unscrew the cap. Insert the back of the cap into the piece that closes the tube. Turn the cap until the tube opens.
• Apply a thin layer of gel to the skin area where there is pain and inflammation, using a gentle massage.
• Close the tube tightly after use.
• Wash your hands after applying the gel, unless they are the treatment area.

If the pain or swelling worsen or persist after 7 days of treatment, consult your doctor.

If you forgot to use Diclokern Forte

If you forgot to apply this medication when it was due, apply the gel as soon as possible and continue with the normal treatment.

Do not apply a double dose to make up for the missed dose.

If you use more Diclokern Forte than you should

If you accidentally ingest Diclokern Forte or if you have used it on a large area of the skin for a long time, you may experience adverse reactions similar to those caused by diclofenac when taken orally (e.g. tablets).

The main symptoms of overdose are: digestive or renal disorders and difficulty breathing.

If you have applied too much of the medication, it is recommended to remove it by washing the affected area with plenty of water, or by removing part of it.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (91 562 04 20), indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Diclokern Forte may produce adverse effects, although not everyone will experience them.

Some rare and very rare adverse effects can be severe:

If you experience any of the following signs of allergy, stop using Diclokern Forte and consult a doctor or pharmacist immediately:

• Rare (observed between 1 and 10 of every 10,000 patients): Skin eruption accompanied by blisters; urticaria (red, elevated patches, often with a sensation of itching and burning).
• Very rare (observed in fewer than 1 of every 10,000 patients): Difficulty breathing or sensation of pressure in the chest (asthma); swelling in the face, lips, tongue, or throat.

Mild adverse effects:

Other adverse effects may occur, but these are usually mild and of short duration. If you notice any of them, consult your doctor or pharmacist as soon as possible.

• Frequent (observed between 1 and 10 of every 100 patients): Eruption, itching, redness, or stinging sensation in the skin after using the product.
• Very rare (observed in fewer than 1 of every 10,000 patients): The skin may be more sensitive to the sun (photosensitivity). Symptoms are: sunburn with itching, swelling, and blisters.
• Unknown frequency (cannot be estimated from available data): Sensation of burning at the application site, dry skin.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Diclokern Forte after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Once opened, discard the tube with the remaining gel after 12 months.

Medicines should not be thrown down the drain or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment..

Composition of Diclokern Forte:

• The active principle is diclofenac dietilamine. Each gram of gel contains 23.2 mg of diclofenac dietilamine (which corresponds to 20 mg of diclofenac sodium).
• The other components (excipients) are: propylene glycol (E-1520), oleic alcohol, isopropyl alcohol, butylhydroxytoluene, dietilamine, liquid paraffin, macrogol cetoestearate ether, carbomer, caprilocaprate of cocoilo, cream fragrance 1876601 (contains hexyl benzoate) and purified water

Appearance of the product and contents of the packaging

Diclokern Forte is a viscous and white gel. It is packaged in an aluminum laminated tube consisting of several layers of low-density polyethylene, aluminum, and high-density polyethylene (inner layer), joined to a high-density polyethylene piece, which is sealed, and provided with a polypropylene cap.

The medicine is presented in a tube with 50, 100, 150 grams of gel.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: June 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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